Blood vessel access and closure devices and related methods of use

ABSTRACT

A medical device may include an outer assembly having a first shaft, a first lumen extending through the first shaft, and an atraumatic first tip removably coupled to a distal end of the first shaft; an inner assembly configured to extend through the first lumen of the outer assembly, the inner assembly including a second shaft, a second lumen extending through the second shaft, and a second tip removably coupled to a distal end of the second shaft, the second tip being configured to pierce tissue; and a plug assembly configured to extend through the second lumen of the inner assembly, the plug assembly including a third shaft and a plug removably coupled to a distal end of the third shaft.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefits of priority under 35 U.S.C.§ 119 to U.S. Provisional Patent Application No. 62/450,257, filed Jan.25, 2017, and to U.S. Provisional Application No. 62/525,839, filed Jun.28, 2017, the entireties of which are incorporated herein by reference.

TECHNICAL FIELD

Embodiments of the present disclosure relate to devices for accessing ablood vessel by creating an opening through a wall of the blood vessel,and for subsequently closing the opening, and related methods of use.

BACKGROUND

Various mechanisms are available for accessing a blood vessel in orderto perform a medical procedure inside the blood vessel or other part ofthe cardiovascular system. However, many conventional techniquesposition a sheath or other member within the blood vessel, restrictingthe field of view within the vessel, and restricting the ability tonavigate tools both proximally and distally of the point of insertion.Additionally, procedure times for conventional techniques may be higherthan optimal.

SUMMARY

In one aspect, the disclosure is directed to a medical device includingan outer assembly having a first shaft, a first lumen extending throughthe first shaft, and an atraumatic first tip removably coupled to adistal end of the first shaft; an inner assembly configured to extendthrough the first lumen of the outer assembly, the inner assemblyincluding a second shaft, a second lumen extending through the secondshaft, and a second tip removably coupled to a distal end of the secondshaft, the second tip being configured to pierce tissue; and a plugassembly configured to extend through the second lumen of the innerassembly, the plug assembly including a third shaft and a plug removablycoupled to a distal end of the third shaft.

The first tip may include a first tip lumen, the second tip may extendthrough the first tip lumen, and the second tip may include a protrusionconfigured to engage with the first tip and secure the first tip to thesecond tip. The protrusion may extend proximally from a proximal end ofthe second tip, and is configured to engage with a proximal end of thefirst tip via a snap-fit. The first tip may include a first bevel at adistal end of the first tip. The second tip may include a second bevelconfigured to pierce tissue at a distal end of the second tip. Thesecond tip may include a first flange extending proximally from thesecond bevel at an angle offset from a longitudinal axis of the secondtip. The first flange may include a first part and a second partpivotable relative to the first part by a hinge. In a firstconfiguration, the second part may extend at a first angle to thelongitudinal axis of the second tip, and in a second configuration, thesecond part may extend at a second angle to the longitudinal axis of thesecond tip, wherein the second angle is different than the first angle.Pulling the inner assembly proximally may cause the second part to pivotfrom the first configuration to the second configuration. The hinge maybe a living hinge. The second tip may include a second tip lumenextending through the second tip, an inner surface surrounding a distalportion of the second tip lumen, and a second flange extending radiallyinward from the inner surface and surrounding a proximal portion of thesecond tip lumen. The plug may be a solid member without lumens, mayinclude a bevel at a distal end, and may include a third flangeextending circumferentially around a portion of the plug, wherein adistally-facing surface of the third flange is configured to abut aproximal-facing surface of the second flange when the plug is extendedthrough the second lumen. The second tip may include a recess at adistal end of the second tip, the recess extending only partially arounda circumference of the second tip, and the plug may include a protrusionconfigured to be received by the recess, the protrusion extending onlypartially around a circumference of the plug. One or more of the firsttip, the second tip, and the plug may be bioresorbable. Each of thefirst tip, the second tip, and the plug may be bioresorbable.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various exemplary embodiments andtogether with the description, serve to explain the principles of thedisclosed embodiments.

FIGS. 1-3, 3A, and 4-6 illustrate a method of accessing a blood vesselfor a procedure, and for sealing the blood vessel after the procedure.

FIG. 7 illustrates various components of a medical kit according to anexample of the present disclosure.

FIGS. 8-12 illustrate an inner assembly having a piercing tip accordingto an example of the present disclosure.

FIGS. 13-18 illustrate an outer assembly having a distal tip accordingto an example of the present disclosure.

FIGS. 19-24 illustrate a plug assembly having a plug according to anexample of the present disclosure.

FIGS. 25-30 illustrate the inner assembly of FIGS. 8-12, the outerassembly of FIGS. 13-18, and the plug assembly of FIGS. 19-24 usedtogether in various configurations.

FIG. 31 is a schematic illustration of an example of closing an openingto a blood vessel using a suture.

FIG. 32 is a schematic illustration of accessing a blood vessel usingmultiple sheaths.

FIG. 33 is a schematic illustration of a filter assembly in a bloodvessel.

FIGS. 34-36 illustrate another embodiment of a piercing tip for use withan inner assembly.

DETAILED DESCRIPTION

Reference will now be made in detail to exemplary embodiments of thepresent disclosure, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like partsor components. The term “distal” refers to the direction that is awayfrom the user or operator and into the patient's body. By contrast, theterm “proximal” refers to the direction that is closer to the user oroperator and away from the patient's body.

The present disclosure is directed to devices for accessing a bloodvessel, such as, e.g., a femoral artery, a carotid artery, or any otherartery or vein. An exemplary method is shown in FIGS. 1-3, 3A, and 4-6using a medical kit. The medical kit is described in more detail withreference to FIGS. 7-30.

Referring to FIG. 7, the medical kit may include an inner assembly 100,an outer assembly 200, a plug assembly 300, and a dilator 400. Dilator400 may be any suitable device configured to dilate a body lumen,including expandable dilators. Dilator 400 may be removably coupled toinner assembly 100 so that dilator 400 and inner assembly 100 may beinserted simultaneously into a blood vessel.

Various portions of inner assembly 100 are shown in FIGS. 8-12. Innerassembly 100 may extend from a proximal end 102 to a distal end 104, andmay include a shaft 106 that is coupled to a piercing tip 108 at distalend 104. The shaft 106 may include one or more lumens extendingtherethrough. Shaft 106 also may include one or more openings 110extending through a wall of shaft 106. In one example, shaft 106 mayinclude two diametrically opposed openings 110 near its distal end.

Piercing tip 108 has a body that extends from a proximal end 109 to adistal end 110, and may include a bevel 111 at distal end 110 that isconfigured to pierce through tissue. Piercing tip 108 also may include aflange 112 that extends proximally from bevel 111. In some examples,flange 112 may lie in the same plane as bevel 111. In some examples,flange 112 extends from only a proximal portion of bevel 111. Flange112, and particularly its proximal-facing surface, may include a tackycoating and/or bioadhesive to help maintain flange 112 against tissue. Alumen 113 may extend from proximal end 109 to distal end 110. Piercingtip 108 may include a circumferential rim 114 at proximal end 109, and acircumferential flange 116 disposed distally of rim 114. The flange 116may extend radially inward from an inner surface 118 of piercing tip108. The flange 116 may have a smaller diameter than rim 114. A lockingarm 120 may extend proximally from rim 114. Locking arm 120 may includea radially-outward extending protrusion 121. Piercing tip 108 also mayinclude a recess 122 at distal end 110, which may be used in a snap fitengagement with a portion of plug assembly 300, as discussed in furtherdetail below. Piercing tip 108 also may include one or more openings 124extending through its body and in communication with lumen 113. In oneexample, piercing tip 108 may include diametrically opposed openings 124that align with openings 110 of shaft 106.

Piercing tip 108 may be coupled to a distal end of shaft 106 via aconnecting member 130. The connecting member 130 may extend outside ofthe one or more lumens of shaft 106 and through openings 110 of shaft106 and openings 124 of piercing tip 108, to secure the piercing tip 108to shaft 106. The connecting member 130 may be a suture, wire, thread,or other suitable connecting member. Opposing ends 132 of connectingmember 130 may extend proximally when piercing tip 108 and shaft 106 arecoupled to one another. In one example, tension may be applied to thoseends 132. Piercing tip 108 may be configured to detach from shaft 106.In one example, tension may be released from one of the ends 132,allowing connecting member 130 to be removed from the device by pullingon the other end 132. In another example, connecting member 130 mayinclude one or more frangible links that are configured to break when asufficient pulling force is applied to ends 132, allowing separation ofpiercing tip 108 from shaft 106.

Referring to FIG. 7, inner assembly 100 may include an access port 150and a conduit 152 at proximal end 102. Access port 150 may be used todeliver various tools through one or more lumens of inner assembly 100,and conduit 152 may be used for suction, irrigation, aspiration, orother fluid-related tasks. In one example, conduit 152 may be used toprovide a saline flush. A pressure sensor may disposed in access port150 or in another suitable location of inner assembly 100 to monitorpressure within a blood vessel.

Various portions of outer assembly 200 are shown in FIGS. 13-18. Outerassembly 200 may extend from a proximal end 202 to a distal end 204, andmay include a shaft 206 that is coupled to a distal tip 208 at distalend 204. The shaft 206 may include one or more lumens extendingtherethrough. Shaft 206 also may include one or more openings 210extending through a wall of shaft 206. In one example, shaft 206 mayinclude two diametrically opposed openings 210 near its distal end.

Distal tip 208 has a body that extends from a proximal end 209 to adistal end 210, and may include a bevel 211 at distal end 210 that isconfigured to clamp onto tissue. In some examples, the bevel 211 may beatraumatic to prevent excessive damage to tissue when used as a clamp.Bevel 211 may include a tacky coating and/or bioadhesive in order tohelp secure bevel 211 against tissue. A gauze or other fabric may becoupled to bevel 211 to absorb excess bodily fluids and to facilitatehealing during closure of an access opening to a blood vessel. Proximalend 209 may include a generally cylindrical portion 215 configured toslide into a lumen of shaft 206. Distal tip 208 also may include aproximally-facing circumferential flange 212 configured to abut thedistal end of shaft 206. A lumen 213 may extend from proximal end 209 todistal end 210. Distal tip 208 also may include one or more openings 224extending through cylindrical portion 215 and in communication withlumen 213. In one example, distal tip 208 may include diametricallyopposed openings 224 that align with openings 210 of shaft 206.

Distal tip 208 may be coupled to a distal end of shaft 206 via aconnecting member 130 that is substantially similar to the connectingmember 130 previously described. The connecting member 130 may extendthrough openings 224 of distal tip 208 and at least partially around acircumference of cylindrical portion 215. The ends 132 of the connectingmember 130 then may be passed through openings 210 of shaft 206, thelumen of shaft 206, and proximally out of shaft 206.

Various portions of plug assembly 300 are shown in FIGS. 19-24. Plugassembly 300 may extend from a proximal end 302 to a distal end 304, andmay include a shaft 306 that is coupled to a plug 308 at distal end 304.The shaft 306 may include one or more lumens extending therethrough.Shaft 306 also may include one or more openings 310 extending through awall of shaft 306. In one example, shaft 306 may include twodiametrically opposed openings 310 near its distal end.

Plug 308 has a body that extends from a proximal end 309 to a distal end310, and may include a bevel 311 at distal end 310. In some examples,the bevel 311 may be a solid member (having no lumens or extensionstherethrough) in order to seal an opening created through a wall of ablood vessel. Proximal end 309 may include a generally cylindricalportion 315 configured receive a distal end of shaft 306 in a lumen 313.Distal tip 308 also may include a circumferential flange 312 configuredto abut flange 116 of inner assembly 100. Lumen 313 may extend fromproximal end 309 toward distal end 310, and may be closed off at adistal end by a proximal surface of bevel 311. Plug 308 also may includeone or more openings 324 extending through cylindrical portion 315 andin communication with lumen 313. In one example, plug 308 may includediametrically opposed openings 324 that align with openings 310 of shaft306. Plug 308 also may include a locking protrusion 330 extendingradially outward from a proximalmost portion of the bevel 311. As shownin FIG. 22, plug 308 may be covered with a graft 340, such as, e.g., anePTFE graft to promote tissue growth after insertion through a bloodvessel wall.

Distal tip 308 may be coupled to a distal end of shaft 306 via aconnecting member 130 that is substantially similar to the connectingmember 130 previously described. The connecting member 130 may extendthrough openings 324 of plug 308 and at least partially around acircumference of cylindrical portion 315. The ends 132 of the connectingmember 130 then may be passed through openings 310 of shaft 306, a lumenof shaft 306, and proximally out of shaft 306.

All or portions of inner assembly 100, outer assembly 200, and plugassembly 300 may be formed from biocompatible materials. Examples ofsuch materials may include, but are not limited to,polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene(ePTFE), ethylene tetrafluoroethylene (ETFE), polyethylene terephthalate(PET), perfluoroalkoxy (PFA), polyether ether ketone (PEEK),polypropylene (PP), silicone, polycarbonate, polyurethane, LDPE, HDPE orthe like. In some embodiments, one or more portions of the innerassembly 100, outer assembly 200, and plug assembly 300, may be formedfrom bioresorbable materials, including, for example, polyglycolide(PGA), polylactide (PLA), and/or polycaprolactone (PCL). Whenbioresorbable materials are used, different bioresorbable materials maybe used that regrade at different rates. In one example, one or more ofpiercing tip 108, distal tip 208, and plug 308 may include abioresorbable material.

FIGS. 25-30 show the relationship of inner assembly 100, outer assembly200, and plug assembly 300. In one example, outer assembly 200 may beconfigured to surround inner assembly 100, and thus, inner assembly 100may have a smaller diameter than outer assembly 200 so as to fit withina lumen of outer assembly 200. Further, plug assembly 300 may beconfigured to slide within a lumen of inner assembly 100 as shown inFIG. 25. Thus, shafts 206, 106, and 306 may be nested in certainconfigurations of the medical kit. Additionally, distal tip 208,piercing tip 108, and plug 308 may be nested in certain configurations,with distal tip 208 surrounding piercing tip 108, and piercing tip 108surrounding plug 308.

Distal tip 208 and piercing tip 108 may have corresponding features thatcooperate to secure distal tip 208 and piercing tip 108 together. Forexample, locking arm 120 of inner assembly 100 may be configured toengage proximal end 209 of distal tip 208. For example, distal tip 208may be advanced distally over piercing tip 108 until locking arm 120clears proximal end 209 of distal tip 208, causing distal tip 208 andpiercing tip 108 to form a locked configuration relative to one another.The protrusion 121 of locking arm 120 may engage proximal end 209 ofdistal tip 208. Also, locking arm 120 may be a cantilevered arm that mayflex radially inward and outward during engagement with distal tip 208.Once locking arm 120 clears proximal end 209, piercing tip 108 may beprevented from moving distally relative to distal tip 208 due to theengagement of locking arm 120 with proximal end 209 of distal tip 208.

Piercing tip 108 and plug 308 also may have corresponding features thatcooperate to secure piercing tip 108 to plug 308. For example, piercingtip 108 includes a recess 122 configured to receive locking protrusion330 of plug 308. Also, flange 116 of piercing tip 108 may be configuredto abut the distally-facing surface of flange 312. Thus, in someexamples, plug 308 may be advanced distally through the proximal end 109of piercing tip 108 until locking protrusion 330 engages with recess122. Once locking protrusion 330 engages with recess 122, plug 308 maybe prevented from moving proximally relative to piercing tip 108 due tothe engagement of locking protrusion 330 and recess 122. In someexamples, the engagement of locking protrusion 330 with recess 122 mayrequire precise circumferential alignment between piercing tip 108 andplug 308. Additionally, plug 308 may be prevented from moving distallyrelative to piercing tip 108 due to the engagement of flange 116 andflange 312.

FIGS. 1-6 illustrate a method of accessing a blood vessel 1000 using themedical kit described with reference to FIGS. 7-30. Referring to FIG. 1,the method may begin with the kit in an insertion configuration whereouter assembly 200 is positioned around inner assembly 100. Blood vessel1000 may first be accessed by guidewire 500 through an opening made byany suitable puncture device (not shown), and then inner assembly 100,outer assembly 200, and dilator 400 may be advanced separately orsimultaneously over guidewire 500. Once dilator 400 pierces throughblood vessel wall 1002, blood may enter a side-hole of dilator 400 andtravel proximally through dilator 400 so as to be visible at proximalend 102, providing a visual indication that the blood vessel 1000 hasbeen accessed by dilator 400. Then, blood vessel 1000 may be accessed bypiercing a wall 1002 with piercing tip 108 (and inner assembly 100) in abevel up configuration where the bevel 111 faces away from the operator.Outer assembly 200 also may be in a bevel up configuration whilepiercing tip 108 is in the bevel up configuration. In a bevel upconfiguration, piercing tip 108 may initially contact tissue only withits distalmost point, whereas, in a bevel down configuration, the faceof bevel 111 may make initial contact with tissue. In the bevel downconfiguration, the proximalmost portion of bevel 111 may contact tissuebefore, or at the same time, as a distalmost portion of bevel 111.

Referring to FIG. 2, an operator may rotate inner assembly 100 and/orouter assembly 200 after blood vessel 1000 has been accessed by piercingtip 108 such that both inner assembly 100 and outer assembly 200 are ina bevel down configuration where bevel 111 and 211 face toward from theuser. In some embodiments, inner assembly 100 may not be rotated afterblood vessel 1000 is accessed by piercing tip 108.

Referring to FIG. 3, once piercing tip 108 is in the bevel downconfiguration within blood vessel 1000, inner assembly 100 may be pulledproximally to cause flange 112 to abut the inner surface of blood vesselwall 1002. As alluded to above, inner assembly 100 may not be rotatedafter piercing tip 108 accesses blood vessel 1000, and inner assembly100 may be pulled proximally while piercing tip 100 is in the bevel upconfiguration to cause flange 112 to abut the inner surface of bloodvessel wall 1002. In some examples, the operator may be required tomaintain a proximal pulling force on inner assembly 100. However, inother examples, a proximal pulling force may be maintained by variousmechanical or electromechanical mechanisms so that the operator is freeto perform other tasks. Referring to FIG. 3A, once flange 112 is securedagainst the inner surface of blood vessel wall 1002, outer assembly 200may be pushed down (distally) such that bevel 211 (and distal tip 208 ofouter assembly) comes into contact with skin or the outer surface ofblood vessel wall 1002, forming a clamp with piercing tip 108. As outerassembly 200 is pushed distally, locking arm 120 (and protrusion 121) ofinner assembly 100 may engage proximal end 209 of distal tip 208,securing piercing tip 108 and distal tip 208 together. Once locking arm120 is engaged with proximal end 209 of outer assembly 200, piercing tip108 may be prevented from moving distally relative to distal tip 208.Piercing tip 108 also may be prevented from moving further proximallydue to the engagement of flange 112 with the inner surface of bloodvessel wall 1002. Tacky coatings and/or bioadhesives applied to thesurfaces of flange 112 and bevel 211 also may help secure piercing tip108 and distal tip 208 in place during closure of the opening in bloodvessel wall 1002.

Once piercing tip 108 and distal tip 208 are secured to one another,dilator 400 and guidewire 500 may be removed from a lumen of innerassembly 100 (FIG. 4), and a suitable therapeutic or diagnosticprocedure may be performed in blood vessel 1000. The procedure may beperformed in the absence of any sheath, scope, or other tool withinblood vessel 1000. This may allow for easier manipulation of toolswithin blood vessel 1000, and for procedures to be performed bothproximally and distally of the opening created in blood vessel wall1002.

After completion of the procedure, the tools used during the proceduremay be removed from blood vessel 1000, and plug assembly 300 may beinserted through inner assembly 100 (FIG. 5) until plug 308 engages withpiercing tip 108 to close the opening. As set forth above, lockingprotrusion 330 of plug 308 may engage with recess 122 of piercing tip108. Also, flange 116 of piercing tip 108 may be abut thedistally-facing surface of flange 312 to prevent plug 308 from enteringblood vessel 1000.

Once piercing tip 108, distal tip 208, and plug 308 are engaged with oneanother, shafts 106, 206, and 306 may be removed by pulling onconnecting member ends 132 as described above. Thus, after completion ofthe procedure, a closure device comprising only piercing tip 108, distaltip 208, and plug 308 may remain coupled to the blood vessel wall 1002.In some examples, the entirety of the closure device may resorb within30 to 90 days. In other examples, where the components of the closuredevice are non-resorbable, the closure device may be removed in asubsequent procedure, if desired.

In an alternative example shown in FIG. 31, distal tip 208 may not beused to close the opening through blood vessel wall 1002. Instead,distal tip 208 and the remainder of outer assembly 200 may be retractedproximally and/or otherwise detached from inner assembly 100 (or notused at all), and a suture knot 3102 may be used to close the openingafter plug 308 has been inserted through the opening. Collagen,hydrogel, or another suitable dressing 3104 may be applied to theopening and/or suture knot 3102 to facilitate healing.

In another example shown in FIG. 32, a second procedural sheath 3202 maybe inserted through inner assembly 100 and into blood vessel 1000. Thesecond procedural sheath may direct and/or divert catheters, tools, andother medical devices into the blood vessel 1000 and may help preventpuncture of an opposing surface of blood vessel wall 1002.

In yet another example shown in FIG. 33, a filter system 3300 may beplaced into blood vessel 1000 downstream of the opening through bloodvessel wall 1002. Placement of the filter system 3300 downstream of theopening may help capture tissue or other materials that come loose andenter the bloodstream, helping to prevent an embolism caused by theloose materials. In one example, the filter system 3300 is used whenblood vessel 1000 is the carotid artery.

FIGS. 34-36 illustrate another embodiment of a piercing tip for use withan inner assembly in the same way that other piercing tips are used withan inner assembly throughout this disclosure. Piercing tip 608 has abody that extends from a proximal end 609 to a distal end 610, and mayinclude a bevel 611 at distal end 610 that is configured to piercethrough tissue. Piercing tip 608 also may include a flange 612 thatextends proximally from bevel 611. Flange 612 will be described in moredetail below. A lumen 613 may extend from proximal end 609 to distal end610. Piercing tip 608 may include a circumferential rim 614 at proximalend 609, and a circumferential flange (not shown) disposed distally ofrim 614, as in embodiments described above. The circumferential flangemay have the characteristics and structure of the like-flange describedin connection with those other embodiments. Two locking arms 620 extendproximally from rim 614, 180 degrees apart from each other. Each lockingarm 620 includes a radially-outward extending protrusion 621. Piercingtip 108 also may include a recess 622 at distal end 610, which may beused in a snap fit engagement with a portion of plug assembly 300, asdiscussed in further detail above. Piercing tip 608 also may include oneor more openings 624 extending through its body and in communicationwith lumen 613, for the same purposes as like-openings described inconnection with other embodiments within this disclosure. In an example,piercing tip 608 may include diametrically opposed openings 624 thatalign with openings 110 of shaft 106.

As shown in FIGS. 34-36, flange 612 includes two parts 612 a and 612 bcoupled together by a pivot/hinge 612 c. Parts 612 a, 612 b and hinge612 c may be constructed as a one-piece, integral structure (forexample, molded) or as multiple pieces coupled together by, for example,a pivot pin. If a one piece structure, hinge 612 c may be a livinghinge, permitting pivoting of part 612 a relative to part 612 b.Piercing tip 608 may be made of any suitable biocompatible material,including bio-resorbable materials or materials suitable for a permanentimplant. It is contemplated that flange 612 may extend around a greaterportion of the circumference of piercing tip 608 than is shown in thefigures. For example, flange 612 may extend around a majority of thecircumference of piercing tip 608, or multiple flanges 612 may extendaround the circumference of piercing tip 608. When multiple flanges 612are utilized, a majority of the circumference of piercing tip 608 may beencompassed by at least one of the flanges 612. Furthermore, while twoparts (612 a and 612 b) and one hinge (612 c) are shown, a given flange612 may include additional parts and/or hinges. For example, one flange612 may include three parts pivotable relative to one another by twohinges. These combinations are only exemplary. Other numbers of partsand flanges also are contemplated. In yet other embodiments, only aminority of the circumference of piercing tip 608 may be covered by aflange 612.

As shown in FIG. 36, piercing tip 608 is configured to have a first,insertion configuration suitable for insertion of piercing tip throughthe blood vessel wall. In that configuration, flange 612 assumes a bentprofile, limiting the overall cross-sectional width of tip 608. In thatprofile, part 612 a is pivoted relative to part 612 b, and out of theplane of part 612 b, Part 612 a assumes a position aligned with thelongitudinal axis of the lumen 613 of tip 608, and adjacent to the outersurface of the body of tip 608.

After insertion of tip 608 within the blood vessel, and pulling back oftip 608, part 612 a will snag against the inner surface of the vesselwall, causing part 612 a to pivot relative to part 612 b and assume thesecond implanted configuration shown in FIGS. 34 and 35. Flange 612 maybe configured so that part 612 a cannot rotate past the plane of part612 b, for example by using a living hinge as hinge 612 c. Flange 612,and particularly its proximal-facing surface, may include a tackycoating and/or bioadhesive to help maintain flange 612 against tissue.

Embodiments of the present disclosure may increase the speed of accessinto the neck for stroke treatments, and also speed up procedural timesduring other procedures, such as, e.g., femoral access. The angled shapeof piercing tip 108 may allow for access into an artery (or other bloodvessel) and provide a larger footprint for inside artery securement.

Although the exemplary embodiments described above have been disclosedin connection with medical devices for insertion into a blood vessel,those skilled in the art will understand that the principles set outabove can be applied to any body lumen and can be implemented indifferent ways without departing from the scope of the disclosure asdefined by the claims. In particular, constructional details, includingmanufacturing techniques and materials, are well within theunderstanding of those of skill in the art and have not been set out inany detail here. These and other modifications and variations are wellwithin the scope of the present disclosure and can be envisioned andimplemented by those of skill in the art.

Other exemplary embodiments of the present disclosure will be apparentto those skilled in the art from consideration of the specification andpractice of the exemplary embodiments disclosed herein. It is intendedthat the specification and examples be considered as exemplary only, anddepartures in form and detail may be made without departing from thescope and spirit of the present disclosure as defined by the followingclaims.

1. A medical device, comprising: an outer assembly having a first shaft,a first lumen extending through the first shaft, and an atraumatic firsttip removably coupled to a distal end of the first shaft; an innerassembly configured to extend through the first lumen of the outerassembly, the inner assembly including a second shaft, a second lumenextending through the second shaft, and a second tip removably coupledto a distal end of the second shaft, the second tip being configured topierce tissue; and a plug assembly configured to extend through thesecond lumen of the inner assembly, the plug assembly including a thirdshaft and a plug removably coupled to a distal end of the third shaft.2. The medical device of claim 1, wherein: the first tip includes afirst tip lumen; the second tip extends through the first tip lumen; andthe second tip includes a protrusion configured to engage with the firsttip and secure the first tip to the second tip.
 3. The medical device ofclaim 1, wherein the protrusion extends proximally from a proximal endof the second tip, and is configured to engage with a proximal end ofthe first tip via a snap-fit.
 4. The medical device of claim 1, whereinthe first tip includes a first bevel at a distal end of the first tip.5. The medical device of claim 1, wherein the second tip includes asecond bevel configured to pierce tissue at a distal end of the secondtip.
 6. The medical device of claim 5, wherein the second tip includes afirst flange extending proximally from the second bevel at an angleoffset from a longitudinal axis of the second tip.
 7. The medical deviceof claim 6, wherein the first flange includes a first part and a secondpart pivotable relative to the first part by a hinge.
 8. The medicaldevice of claim 7, wherein: in a first configuration, the second partextends at a first angle to the longitudinal axis of the second tip; andin a second configuration, the second part extends at a second angle tothe longitudinal axis of the second tip, wherein the second angle isdifferent than the first angle.
 9. The medical device of claim 8,wherein pulling the inner assembly proximally causes the second part topivot from the first configuration to the second configuration.
 10. Themedical device of claim 7, wherein the hinge is a living hinge.
 11. Themedical device of claim 1, wherein the second tip includes: a second tiplumen extending through the second tip; an inner surface surrounding adistal portion of the second tip lumen; and a second flange extendingradially inward from the inner surface and surrounding a proximalportion of the second tip lumen.
 12. The medical device of claim 11,wherein the plug: is a solid member without lumens; includes a bevel ata distal end; and includes a third flange extending circumferentiallyaround a portion of the plug, wherein a distally-facing surface of thethird flange is configured to abut a proximal-facing surface of thesecond flange when the plug is extended through the second lumen. 13.The medical device of claim 1, wherein: the second tip includes a recessat a distal end of the second tip, the recess extending only partiallyaround a circumference of the second tip; and the plug includes aprotrusion configured to be received by the recess, the protrusionextending only partially around a circumference of the plug.
 14. Themedical device of claim 1, wherein one or more of the first tip, thesecond tip, and the plug are bioresorbable.
 15. The medical device ofclaim 1, wherein each of the first tip, the second tip, and the plug arebioresorbable.